Product News and Recalls

The U.S. Judicial Panel on Multidistrict Litigation has ordered the transfer of all federal lawsuits filed over allegedly defective IVC filters made by medical device manufacturer C.R. Bard, Inc. to the District of Arizona following the appearance at a July 30 hearing of lead IVC filter attorney Ramon Rossi Lopez.

Lopez, founding partner of Lopez McHugh LLP, argued in favor of the transfer at the hearing in San Francisco. Comprised of seven federal judges representing various federal circuit courts, the MDL panel had to decide whether the lawsuits against Bard share common questions of fact and should be consolidated into MDL litigation to make more efficient use of the parties’ and the courts’ resources. The ruling will affect hundreds of patients who have been injured by inferior vena cava (IVC) filters.

“This is the correct decision by the judicial panel and welcome news for patients,” said Lopez, who represents dozens of plaintiffs injured by IVC filters that have broken or migrated through patients’ bodies. “It was inarguably in the best interests of the courts and everyone involved to consolidate these cases into multidistrict litigation.”

An IVC filter is a small, cone-shaped, cage-like medical device implanted into a patient’s inferior vena cava, the large vein that carries oxygen-depleted blood from the lower body up to the heart. IVC filters are intended to prevent an embolism, a blood clot that has broken free of a deep vein in the legs, from reaching the heart or lungs.

The MDL decision came just a few weeks after yet another warning from the U.S. Food and Drug Administration to Bard over the marketing and distribution of its IVC filters. On July 13, 2015, the FDA issued a warning letter to Bard over safety violations its inspectors noted at the company’s facilities in Tempe, Ariz., and Queensbury, N.Y. Among the violations, the agency warned Bard, which is headquartered in New Jersey, that the company’s post-market surveillance system, which is supposed to raise safety signals to the FDA and public, was so inadequate that it violated federal law.

The FDA noted numerous examples wherein Bard reported serious patient injuries, including death, as if no injury had occurred and/or utterly failed to report numerous device malfunctions that could have caused death or serious patient injury. FDA also found that Bard’s manufacturing process violated federal law as Bard failed to enact a cleaning procedure to ensure that the toxic chemicals, including acids, used to manufacture these devices were removed prior to distribution. The FDA also demanded that Bard immediately stop marketing its Recovery Cone Removal System because Bard had been selling these devices “without marketing clearance or approval” as required by federal law.

The FDA previously issued warnings in 2010 and again in 2014, recommending that doctors remove IVC filters after the risk of embolism has passed. The warnings came after reports began mounting that some IVC filters had migrated through patients’ bodies or had fractured, sending fragments of the device to their hearts and lungs. Serious injuries to patients’ hearts, lungs and vascular systems, including the inferior vena cava itself, have been reported, and several people have died.

Lopez and co-counsel recently won compensation from Bard for injuries suffered by a Nevada man, Kevin Phillips, who had been implanted with a Bard Recovery Filter in 2005. The IVC filter failed to remain in place and migrated through Phillips’ vascular system, piercing his heart and forcing him to undergo open-heart surgery in 2010.

That settlement successfully secured by Lopez McHugh brings to a close only one of dozens of lawsuits against Bard. Formation of a MDL would give the people hurt by these devices a more organized and efficient forum in which to obtain the compensation and justice they deserve for their injuries. More plaintiffs are expected to come forward as the risks related to the long-term use of IVC filters become more widely known.

Lopez McHugh has compiled resources to assist those who may have been injured by a defective IVC filter. For more information, please visit the firm’s website.

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